FDA Approved First Dengue Vaccine With Some Restrictions

Dengvaxia, the first vaccine for dengue was approved in 19 countries and European Union by the US Food and Drug Administration (FDA) to prevent dengue among patients aged 9-16 years living in endemic areas who had previous laboratory-confirmed dengue infection.

It is a live inactivated vaccine given via injection. Two more injections follow the first dose after 6 and 12 months.

‘Utmost care should be taken while giving Dengvaxia to people whose prior infection status is unknown, as infection induced by the vaccine can result in fatal dengue disease.’

The vaccine was found effective in 76% individuals among 35000 living in endemic areas with previous dengue infection aged 9 to 16 years.

Common side effects reported with the new vaccine are headache, muscle pain, joint pain, fatigue, etc. These effects decrease after each subsequent dose of the vaccine.

"Dengvaxia appears to act as a first dengue infection - without actually infecting the person with wild-type dengue virus - such that a subsequent infection can result in severe dengue disease," the FDA says.

Therefore, the FDA advises healthcare professionals to identify individuals for prior dengue infection to avoid vaccinating persons who have not been previously infected by the dengue virus.

Confirmation of the previous infection can be established through a medical record of the patient's having already had a laboratory-confirmed dengue infection or through serologic testing before vaccination.



Source: Medindia